Press Release

Cape Cod Clinical Research, Inc. (CCCRI), a full-service contract research organization, today announced the launch of TrialDOCS™ v2, a web-based document management solution that has been fully validated in compliance with the FDA’s 21 CFR Part 11.

As life sciences organizations move towards alternate methods to monitoring for data quality and study conduct in compliance with the FDA’s 2011 “Draft Guidance for Industry Oversight of Clinical Investigations—A Risk-Based Approach,” a validated TrialDOCS™ helps investigative sites, pharmaceutical and biotechnology companies access, manage and track all of the regulatory and source documentation required for clinical trials to be monitored remotely.

“Remote monitoring is a concept whose time has finally come to the U.S.,” says William Baker, President and founder of CCCRI. “By providing organizations with a secure system to manage all documentation in a clinical trial—one of the most inefficient processes of clinical research—remote monitoring can be successfully realized, with monitoring costs reduced by as much as 30-50%.”

Upon completion of a 12-month long, rigorous validation implementation, TrialDOCS™ is now a validated system with a set of processes capable of withstanding regulatory audit. It’s a robust, easy-to-use solution for sponsors, investigative sites, auditors and monitors to access and collaborate on study documentation.

Features and functions of TrialDOCS™ include the ability to:

• Manage all study documentation and records, including contracts, protocols, investigator brochures, SOPs, in one secure central repository which is controlled access through password protection
• Access documents from any location, system or device
• Ensure all communications are readily available to support regulatory submissions
• Utilize system regardless of paper file location
• Store complete electronic copy of files
• Communicate and collaborate with other users on workflows
• Access documents and work within the TrialDOCS™ platform remotely
• Provide technical support services

About CCCRI

CCCRI is a full-service contract research organization based in the hotbed of biotech innovation in Massachusetts. Through the CCCRI global network of experienced industry professionals and technology partners, we have conducted more than 30 clinical trials in oncology, CNS, cardiovascular and respiratory therapies for leading pharmaceutical organizations, as well as semi-virtual biotechnology companies.

For a demo of TrialDOCS™, stop by booth #613 at the ACRP in Houston, April 14-17. For more information about CCCRI, please visit: www.cccri.com.

Last updated on: 10/04/2012 16:00:02